Intensive Insulin Therapy in Non-diabetic Patients With Acute Myocardial Infarction and Hyperglycaemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-06-30

Brief Summary

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Hyperglycemia at admission has been associated with bad prognosis in patients with acute myocardial infarction (AMI). The clinical benefit of intensive treatment with insulin has been evaluated in diabetic patients admitted to intensive care units. The aim of our study was to assess the short-term effects and the safety of strict glycemic control in subjects with AMI and hyperglycemia without a previous history of diabetes.

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Detailed Description

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Twenty-eight non-previously diabetic patients admitted with AMI and hyperglycemia were randomized to two treatment arms, administered during the first 48 hours: the intensive group (n=13) received intravenous insulin with target glycemia levels of 80-110mg/dL, while the conventional group (n=15) received subcutaneous insulin only when glycemia was ³ 160mg/dL. High-sensitivity C-reactive protein (HS-CRP) was determined at 48 hours and before discharge and an oral glucose tolerance test (OGTT) was performed at 1 month.

Conditions

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Diabetes Hyperglycemia Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Serum saline

Group Type SHAM_COMPARATOR

Insulin

Intervention Type DRUG

intravenous continuous insulin infusion for 48 hours

Interventions

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Insulin

intravenous continuous insulin infusion for 48 hours

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Confirmed diagnosis of AMI, either with or without ST segment elevation
2. Presence of high blood glucose at admission with no previously known diabetes mellitus (DM)

Exclusion Criteria

1. Age under 18 years old
2. History of DM
3. Presence of other cardiopathies (dilated cardiomyopathy, valvular or hypertrophic heart disease)
4. Unstable AMI patients (haemodynamic instability or arrhythmic disorders)
5. Platelet aggregation or coagulation disorders
6. Severe conditions with an estimated short (under 1 year) life expectancy
7. Participation in other trials
8. Patient refusal to participate in the study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No